MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN922891
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".See associated mdrs 9681900-2022-00032 and 9681900-2022-00033.
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).Three lma proseal were returned from customer on ground of "the red cap of the manual vent is missing".There was no patient involvement in the incident.There was no returned usage record card listing the date of initial use of the devices till its last use.There was no invoice date and invoice number given for validity of warranty.The device was manufactured in 2019.The red plug cap of the device was observed broken at the first glance upon receipt.The reported failure was verified as the lma could not hold cuff inflation with the red plug cap damage /missing.The outer profile of the return complaint samples looks yellowish / discolored due to multiple reuses.The red plug and its cap were the same component produced in the same molding.In order to simulate the process of shutting and opening of the red plug cap, a retained sample was used.It was observed that the red plug cap will not be stressed when it was handled properly.Dhr was reviewed.No abnormality was found.The customer is reminded that lma reusable is made of soft silicone rubber.It should be handled with care for re-using it and it is not supposed to hold the body weight of the device with the red plug cap itself.In addition, in case the red plug cap of the device was tangled with other objects, try not to use abrupt force to pull it.The root cause of the failure concluded as method of use related.
Event or Problem Description
It was reported that "the red cap of the manual vent is missing" while in use on patient.Further information states that there were no issues with deflation/inflation of the cuff during use and that this was a re-sterilized device.An inflation/deflation test occurred prior to use however the missing cap was not noted.Patient status reported as "fine".See associated mdrs 9681900-2022-00032 and 9681900-2022-00033.

• Brand Name: LMA PROSEAL SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15852634
• Report Number: 9681900-2022-00031
• Device Sequence Number: 6525809
• Product Code: CAE
• UDI-Device Identifier: 15060112318730
• UDI-Public: 15060112318730
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN922891
• Device Catalogue Number: 150040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYSTERECTOMY; HYSTERECTOMY
• Patient Sex: Unknown